Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2026
    • The 2026 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Educational Assets
    • Manufacturer Search
    • Podcasts
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Views
    • Video
  • 2026 Leadership
    • 2025 Winners
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe

Grifols Receives ISO 13485:2003+AC:2009 Quality Management Certification for its Medical Devices

January 18, 2012 By AxoGen, Inc.

LOS ANGELES/PRNewswire/ — Grifols, a global healthcare
company and biopharmaceutical manufacturer based in Barcelona, Spain, announced
that its U.S. diagnostic and hospital divisions have received ISO
13485:2003+AC:2009 certification, an international quality standard that sets
forth voluntary benchmarks for the design, manufacture and distribution of
medical devices.

Grifols is the third largest global producer of medicines
derived from human plasma and a manufacturer of diagnostic tools, hospital
products and medical devices. ISO 3485:2003+AC:2009 certification demonstrates
a company’s adherence to a quality management system that administers and
oversees a wide range of safety, compliance and regulatory standards related to
medical devices. 

Grifols’ medical devices are produced in Barcelona,
Spain and are distributed in
the U.S. through its Miami location. 

About Grifols

Grifols is a global pharmaceutical company develops and produces plasma-derived
therapies and manufactures hospital pharmacy products, intravenous solutions,
diagnostic tools and medical devices. As the third largest global producer of
plasma therapies, Grifols has a presence in more than 90 countries and is the
world leader in plasma collection, with 147 plasma donation centers across the U.S. The
company’s class A shares have been listed on the Spanish Stock Exchange since 2006 and have been part of the Ibex-35 since 2008. In 2011, the
company listed non-voting class B shares on the Mercado Continuo (MCE:GRF.P)
and on the U.S. NASDAQ via ADRs.  

About ISO

The International Organization for Standardization (ISO) is the world’s largest
developer and publisher of international standards that apply to business,
government and society. ISO is a network of the national standards institutes
of 163 countries, with a central secretariat in Geneva, Switzerland
that coordinates the system. ISO is a non-governmental organization that forms
a bridge between the public and private sectors and enables consensus to be
reached on solutions that meet the requirements of businesses and the broader
needs of society.

Posted by Sean Fenske, Editor-in-Chief, MDT

Related Articles Read More >

The most innovative medical devices of 2026
An illustration showing Corcym's Memo 4D Curve's laser-cut nitinol core.
Laser-cut nitinol and a layered design let these cardiac implants flex
Reconstructed 3D fluorescence image of the stained biohybrid mesh-tissue integration. The red, green, and blue colors correspond to the mesh, F-actin, and nuclei, respectively.
Researchers mesh electronics with human cells to develop living battery
A photo of the Paradromics Connexus brain-computer interface on a fingertip.
How Paradromics designed its Connexus brain-computer interface system
“mdo
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest medical device business news, application and technology trends.

DeviceTalks Weekly

See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

New MedTech Resource

Medical Tubing

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to our E-Newsletter
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2026 Arrowfly, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of Arrowfly LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2026
    • The 2026 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Educational Assets
    • Manufacturer Search
    • Podcasts
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Views
    • Video
  • 2026 Leadership
    • 2025 Winners
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe